Ex Parte Dosmann

Board of Patent Appeals and Interferences

May 25, 2011

10367690 (B.P.A.I. May. 25, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/367,690 02/19/2003 Andrew J. Dosmann MSE #2651 1935
71331 7590 05/25/2011
NIXON PEABODY LLP
300 S. Riverside Plaza, 16th Floor
CHICAGO, IL 60606-6613
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
05/25/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANDREW J. DOSMANN
__________

Appeal 2011-002033
Application 10/367,690
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-10, 12-17, and 25-27. We have jurisdiction
under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claims 1 and 10 are representative of the claims on appeal, and read
as follows:
1. A lance adapted to harvest a sample for an optical format, the lance
comprising:
a lance body, said lance body defined by a multisided tube wherein
each side is planar and of a material that allows transmission of light
sufficient for optically reading said sample within the lance body, said
multisided tube including a first end, said first end having a sharp point
adapted to pierce skin and harvest said sample.

10. An optical format with an integrated lance, comprising:
a housing, said housing having a first side and a second side, openings
in said first side and said second side for passage of light through said
housing; and
a lance defined by at least one flat surface, the lance being adapted to
harvest said sample and being mounted in said housing, said lance formed of
translucent material sufficient for optically reading the sample, said lance
having a sharp end that is adapted to pierce skin and harvest said sample.

The following grounds of rejection are before us for review:
I. Claims 1, 5, and 25 stand rejected under 35 U.S.C.§ 102(b) as
being anticipated by Humphrey.
1

II. Claims 2 and 3 stand rejected under 35 U.S.C.§ 103(a) as being
rendered obvious by the combination of Humphrey and Schenk.
2

III. Claim 4 stands rejected under 35 U.S.C. §103(a) as being rendered
obvious by the combination of Humphrey, Schenk, and Smart.
3

1
Humphrey, US 5,607,401, issued Mar. 4, 1997
2
Schenk et al., US 5,545,174, issued Aug. 13, 1996.
3
Smart et al., US 5,801,057, issued Sep. 1, 1998.
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IV. Claims 6, 7, and 9 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Humphrey and Smart.
V. Claim 8 stands rejected under 35 U.S.C. §103(a) as being rendered
obvious by the combination of Humphrey and Comley.
4

VI. Claims 10, 12, 15-17, and 26-29 stand rejected under 35 U.S.C.
§103(a) as being rendered obvious by the combination of Smart
and Humphrey.
VII. Claim 13 stands rejected under 35 U.S.C. §103(a) as being
rendered obvious by the combination of Smart, Humphrey, and
Schenk.
VIII. Claim 14 stands rejected under 35 U.S.C.§ 103(a) as being
rendered obvious by the combination of Smart, Humphrey, and
Comley.
We affirm.
ISSUE (Rejections I-IV)
Has the Examiner established by a preponderance of the evidence that
Humphrey anticipates the lance of claim 1?

FINDINGS OF FACT
FF1 The Specification teaches that the invention is drawn to a lance and
optical format to harvest a small blood sample, wherein the sample can be
analyzed with conventional transmission spectroscopy (Spec. 1).

4
Comley et al., US 6,652,809 B1, issued Nov. 25, 2003.
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FF2 The Specification further teaches that capillary action is used to draw
sample into the lance, where it reacts with reagents coated on the walls of
the capillary, producing a color change (id.).
FF3 According to the Specification:
The optical format with integrated lance . . . is used to pierce
the skin of a patient with the sharp point . . . . Once a drop of
blood appears at the puncture site, the tip or first end . . . of the
lance . . . is returned to the drop of blood and capillary action
draws a sample into the square channel . . . . Another
embodiment would leave the lance below the surface of the skin
until capillary action or vacuum assisted capillary action
obtains a sample. The sample is allowed to react with the dried
chemistry . . . coated onto the capillary walls which produces a
color change to the sample. The change in color is proportional
to analyte concentration. The sample is then read with
transmission spectrometry by passing a monochromatic
collimated beam of light through the portion of the lance . . . in
the housing . . . by passing the beam through one of the
openings . . . in the housing . . .

(Id. at 4.)
FF4 The anticipation rejection (Rejection I) may be found at pages 4-5 of
the Answer. As Appellant does not argue the claims separately, we focus
our analysis on claim 1, and claims 5 and 25 stand or fall with that claim.
See 37 C.F.R. § 41.37(c)(1)(vii).
FF5 Specifically, the Examiner finds that Humphrey teaches a lance body
“of a material that allows transmission of light (column 2 lines 43-45,
column 4 lines 5-15, column 12 lines 15-30, and column 14 lines 1-6)
sufficient for optically reading said sample within the lance body (column 2
lines 43-45)” (Ans. 4).
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FF6 The Examiner finds further that “an optical reading and/or analysis
may be performed solely by the eyes of a patient or clinical technician
reading for example the color-coded results of an electrochemical reaction of
bodily fluid with an analytical reagent” (id. at 20).
FF7 Specifically, Humphrey is drawn to a flexible, polymeric hypodermic
needle or lancet (see Humphrey, col. 2, ll. 27-30), which can be made to be
clear or light transmissive to permit the blood or medication within to be
viewed (see id. at col. 2, ll. 43-44).
FF8 Humphrey teaches that the needles or lancets according to the
invention are less costly to manufacture than conventional hypodermic
devices, and may be destroyed or rendered harmless by incineration (see id.
at col. 2, ll. 50-54).

PRINCIPLES OF LAW
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim. See
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001).
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art. See In re American
Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“An essential purpose of patent examination is to fashion claims that are
precise, clear, correct, and unambiguous. Only in this way can uncertainties
of claim scope be removed, as much as possible, during the administrative
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process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Moreover, it is
during prosecution that applicants have “the opportunity to amend the claims
to obtain more precise claim coverage.” American Academy, 367 F.3d at
1364. We also decline to read limitations from the Specification into the
claims, a practice that the Court of Appeals for the Federal Circuit, our
reviewing court, cautions against. See SuperGuideCorp. v. DirecTV
Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though
understanding the claim language may be aided by explanations contained in
the written description, it is important not to import into a claim limitations
that are not part of the claim. For example, a particular embodiment
appearing in the written description may not be read into a claim when the
claim language is broader than the embodiment.”).

ANALYSIS
As to Rejection I, Appellant argues that Humphrey does not disclose,
teach, or suggest a lance body „of a material that allows transmission of light
sufficient for optically reading said sample within the lance body,‟ as recited
in claim 1” (App. Br. 8). According to Appellant, while Humphrey teaches
that the needle is clear to permit viewing of the blood sample within, that is
very different from a material that is useful for optically reading a sample
(see id. at 8-9). Appellant asserts that the lance of claim 1 “is of a much
more specialized type of material – one that allows transmission of light
sufficient for optically reading a sample” (id. at 9). Appellant cites page 4 of
the Specification (see FF3) to support their contention that “the present
[S]pecification makes clear that a material „sufficient for optically reading
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said sample‟ requires substantially more than Humphrey‟s clear material for
„permit[ting] the blood or medication within to be viewed‟” (id. at 9-10).
Claim 1 is drawn to a product, that is a lance, wherein the lance body
is defined by a body “that allows transmission of light sufficient for optically
reading said sample within the lance body.” We agree with the Examiner
that the polymeric lancet of Humphrey is made of a material that allows for
the transmission of light sufficient for optically reading a sample, for
example, such as optically reading a color change by visual inspection.
Moreover, although the Specification discusses using transmission
spectrometry (see FF3), the Specification does not appear to define “optical
reading of a sample” as being limited to such. Thus, the claim is not limited
to only those materials that would allow for reading the sample by
transmission spectrometry. And while the Appellant asserts that the
polymeric material of Humphrey would not be suitable for reading by such a
method, they have provided no evidence to support that assertion, and
arguments of counsel cannot take the place of evidence in the record. See In
re Scarbrough, 500 F.2d 560, 566 (CCPA 1974).
As to Rejection II, Appellant argues that Schenk does not remedy the
deficiencies of Humphrey, and reiterate the arguments made with respect to
Rejection I (see App. Br. 12). We thus affirm this rejection for the reasons
set forth above with respect to Rejection I.
As to Rejection III, Appellant argues that Smart does not remedy the
deficiencies of Humphrey and Schenk, and reiterate the arguments made
with respect to Rejection I (see id. at 12-13). We thus affirm this rejection
for the reasons set forth above with respect to Rejection I.
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As to Rejection IV, Appellant argues that Smart does not remedy the
deficiencies of Humphrey, and reiterate the arguments made with respect to
Rejection I (see id. at 13). We thus affirm this rejection for the reasons set
forth above with respect to Rejection I.

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that Humphrey anticipates the lance of claim 1. We thus affirm
Rejections I-IV.

ISSUES (Rejections V-VIII)
Has the Examiner established by a preponderance of the evidence that
the combination of Humphrey and Comley renders obvious the lance of
claim 8?
Has the Examiner established by a preponderance of the evidence that
the combination of Smart and Humphrey renders obvious the optical format
of claim 10?

FINDINGS OF FACT
FF9 The Examiner‟s statement of Rejection V may be found at page 11 of
the Answer.
FF10 Specifically, the Examiner finds that Humphrey teaches the invention
of claim 8, except “for expressly disclosing [that] the material is fused
silica” (Ans. 11).
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FF11 The Examiner notes that Humphrey teaches the use of a material that
comprises in part randomly dispersed glass fibers (see id.).
FF12 The Examiner also finds that “[i]t is well known in the art of bodily
piercing and fluid sampling lancets to substitute teachings of well known
materials to improve the efficacy of the lancet to function as an optical-
based diagnostic lancet” (id.).
FF13 The Examiner cites Comley for teaching “blood-receiving translucent
capillary tubes comprising fused silica material in a member (column 3 lines
56-61)” (id.).
FF14 Specifically, Comley teaches:
Capillaries may be manufactured from a range of translucent
materials, e.g. plastics (such as perspex), glasses (such as fused
silica) and quartz. It is preferred that the material gives a low
background reading in the optical assay method used. Glasses
and quartz are especially preferred, particularly fused silica
which demonstrates low phosphorescence.

(Comley, col. 3, ll. 56-62.)
FF15 The Examiner concludes that it would have been obvious to use the
fused silica of Comley in the lancet of Humphrey “to achieve the predictable
results of providing an optically transparent lance tube” (Ans. 11).
FF16 The Examiner‟s statement of Rejection VI may be found at pages 11-
16 of the Answer. As Appellant does not argue the claims separately, we
focus our analysis on claim 10, and claims 12, 15-17, and 26-29 stand or fall
with that claim.
FF17 The Examiner finds that Smart teaches an optical format with an
integrated lance that meets the limitations of claim 10, except that Smart
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fails to disclose that the tube is defined by at least one flat surface (see Ans.
11-12).
FF18 The Examiner finds, however, that “it is well known in the art of
bodily piercing and fluid sampling lancets to substitute one cross-sectional
shape for an alternate one” (id. at 12).
FF19 The Examiner cites Humphrey for teaching “a lancet defined by a
multisided tube (the hollow triangular tube as best seen in Figure 51)
(column 14 lines 51-54) wherein each side is planar and defined by a flat
surface (each side of the hollow triangular tube is planar as best seen in
Figure 51) (column 14 lines 51-54)” (id. at 12-13).
FF20 We note further that Humphrey teaches:
An open trough or "V" shaped puncturing part was selected as
ideal. Previous research has shown that "V" shaped needles
require less force to puncture the skin than do conventional
round needles. Further, a "V" shape would lend itself to
unhardened metals, and composite materials, as well as to
hardened stainless steel. A "V" shape could also be formed with
a novel, plow shaped structure at the tip which would separate
and push aside the tissue to reduce coring.

(Humphrey, col. 3, ll. 50-61.)
FF21 The Examiner concludes that it would have been obvious to combine
the lancet tube characteristics of Humphrey comprising a flat surface with
the lancet tube characteristics of Smart “to achieve the predictable result[ ]
of providing an alternate lance body cross-sectional shape to aid in
harvesting a blood sample with a lance body” (Ans. 13).

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PRINCIPLES OF LAW
The Supreme Court has recently emphasized that “the [obviousness]
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
KSR Int’l v. Teleflex Inc., 550 U.S. 398. 418 (2007). “The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” Id. at 416. Moreover, an
“[e]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301
(CCPA 1982).

ANALYSIS
As to Rejection V, Appellant argues that Comley cannot be combined
with Humphrey because Humphrey teaches away from such a combination
(see App. Br.13). Specifically, Appellants argue that Humphrey teaches the
use of a low cost material (see id. at 10), and thus the ordinary artisan would
not consider modifying it with fused silica (see id. at 13).
Appellant‟s arguments are not found to be convincing. Humphrey
teaches the advantages of having a lance body that is translucent to light, and
as taught by Comley, both polymers such as plastic and fused silica are
known by the ordinary artisan to be translucent materials (see e.g., FF14).
The ordinary artisan would also understand the disadvantages, as well as the
benefits of different types of materials, such as fused silica and plastic. See,
e.g., In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994) (“[a] known or obvious
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composition does not become patentable simply because it has been
described as somewhat inferior to some other product for the same use”).
Thus, we agree with the Examiner that it would have been obvious to
another type of translucent material, such as fused silica, in the lancet of
Humphrey.
As to Rejection VI, Appellant argues first that that the combination of
Smart and Humphrey does not result in the claimed optical format, because,
as argued in response to the anticipation rejection, Appellants assert that the
needle of Humphrey “is not „formed of a translucent material sufficient for
optically reading a sample‟” (App. Br. 14). That argument is not found to be
convincing for the reasons set forth above with respect to the anticipation
rejection. We further note that the Examiner did not rely on Humphrey for
teaching the use of a translucent material, but instead found that Smart
teaches that the lance is formed in part of a translucent material for optically
reading the sample (see Ans. 12), and Appellant has not pointed to any error
in that fact finding. Rather, the Examiner relied upon Humphrey for
teaching a lancet defined by a multisided tube wherein the sides of the tube
are planar (see id., see also FF19).
Appellant argues further that the ordinary artisan would not combine
Humphrey with Smart, as the device of Smart has a small sampling chamber
that has a volume less than one microliter, whereas the device of Humphrey
is directed to a device for withdrawing relatively large amounts of blood (see
App. Br. 14). Moreover, Appellant asserts that “Humphrey has no relevance
to optically testing analytes,” and that because Humphrey teaches the low
cost of its device, one would not modify it for optical testing (id. at 15).
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Finally, Appellant argues that the modes of operation of Humphrey and
Smart are different, as Smart relies on capillary action to drawn in fluid
gathered on the surface of the skin, whereas Humphrey uses a force or
vacuum to draw in or expel fluid (see id.).
As noted above, the Examiner relied upon Humphrey for teaching a
lancet having a cross-section wherein the cross-section has at least one flat
side. Thus, we agree with the Examiner that it would have been obvious to
use any known lance cross section, such as that taught by Humphrey, for the
cross-section of the lance of Smart. See In re Keller, 642 F.2d 413, 425
(CCPA 1981) (“The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference; nor is it that the claimed invention must be expressly
suggested in any one or all of the references. Rather, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art”.) Moreover, Appellant has provided no evidence or
sound scientific reasoning as to why the ordinary artisan would not expect
that cross-section to function in the device of Smart.
As to Rejection VII, Appellant argues that Schenk does not remedy
the deficiencies of the combination of Smart and Humphrey (see App. Br.
15-16). As to Rejection VIII, Appellant argues that Comley does not
remedy the deficiencies of the combination of Smart and Humphrey (see
App. Br. 16). Those arguments are not found to be convincing for the
reasons set forth above with respect to the response to the arguments as to
Rejection VI.

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CONCLUSIONS OF LAW
We conclude that the Examiner established by a preponderance of the
evidence that the combination of Humphrey and Comley renders obvious the
lance of claim 8. We thus affirm Rejection V.
We further conclude that the Examiner has established by a
preponderance of the evidence that the combination of Smart and Humphrey
renders obvious the optical format of claim 10. We thus affirm rejections
VI-VIII.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)§ 41.50(b).

AFFIRMED

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